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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00614744 |
Purpose
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18-24 months of age. The study will enroll 168 infants with signs of hypoxic-ischemic encephalopathy at 16 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant, Newborn Hypoxia, Brain Hypoxia-Ischemia, Brain Encephalopathy, Hypoxic-Ischemic Hypoxic-Ischemic Encephalopathy Ischemic-Hypoxic Encephalopathy |
Procedure: Hypothermia Procedure: Normothermic Control |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Evaluation of Systemic Hypothermia Initiated After 6 Hours of Age in Infants ≥36 Weeks Gestation With Hypoxic-Ischemic Encephalopathy: A Bayesian Evaluation. A Protocol for the NICHD Neonatal Research Network |
| Estimated Enrollment: | 168 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
|
Procedure: Hypothermia
Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
|
|
2: Active Comparator
Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
|
Procedure: Normothermic Control
Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
|
Hypoxic-ischemic encephalopathy (HIE) is a rare, but life-threatening condition characterized by acute or subacute brain injury due to asphyxia. In most cases the underlying cause and timing of injury are unknown, but many cases are diagnosed at or shortly after birth.
According to the World Health Organization, more than 722,000 children died from birth asphyxia and birth trauma worldwide in 2004. An estimated 50-75 percent of infants with severe (stage 3) HIE will die, with 55 percent of these deaths occurring in the first month.
The incidence of long-term complications depends on the severity of HIE. Up to 80 percent of infants who survive stage 3 HIE develop significant long-term neurological disabilities - mental retardation, epilepsy, and cerebral palsy with hemiplegia, paraplegia, or quadriplegia; 10-20 percent develop moderately serious disabilities; and up to 10 percent are normal.
Because animal data suggests that brain injury from HIE evolves over several hours to days after the initial asphyxic insult, induced hypothermia holds promise as a neuroprotective therapy. Additional trials are needed to help define the most effective cooling strategies.
With this in mind, and knowing that many babies with HIE arrive at neonatal intensive care units several hours after birth, this study will evaluate the safety and efficacy of initiating hypothermia 6-24 hours after birth.
Study subjects: Infants born at 36 0/7ths weeks or greater gestational age that have been diagnosed with neonatal depression, perinatal asphyxia, or encephalopathy. The goal is to enroll 168 subjects.
Stratification: After informed consent is obtained, infants will be randomized to either a hypothermia arm (with a target esophageal temperature of 33.5°C) or a control arm (37.0°C) for 96 hours. Enrolled infants will be stratified by age of enrollment (≤ 12 and > 12 hours) and stage of encephalopathy (moderate or severe).
Informed Consent: Parents of eligible infants will be approached for consent to enroll in the study if the infant has a high probability of acute hemodynamic compromise, as defined above. Subsequent screening will determine whether the infant meets all inclusion criteria.
Randomization: eligible and consented infants will be randomly assigned to either a hypothermia intervention group, or a non-cooled (control) group.
Study Intervention: Induced whole-body hypothermia (with a target esophageal temperature of 33.5°C) or a control group (37.0°C) for 96 hours.
Interim Study Interruptions: None to date.
Eligibility| Ages Eligible for Study: | up to 24 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Infants with a high probability of acute hemodynamic compromise, such as those with:
NOTE: These inclusion criteria are identical to the NICHD Neonatal Research Network's 2005 Hypothermia study (see links below), except for the time of entry (6-24 hours vs. < 6 hours of age).
Exclusion Criteria:
Contacts and Locations| Contact: Abbot R. Laptook, MD | (401) 274-1122 | alaptook@WIHRI.org |
| Contact: Rosemary D. Higgins, MD | (301) 496-5575 | higginsr@mail.nih.gov |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Waldemar A. Carlo, MD 205-934-4680 wcarlo@peds.uab.edu | |
| Contact: Monica V. Collins, RN BSN (205) 934-5771 mcollins@peds.uab.edu | |
| Principal Investigator: Waldemar A. Carlo, MD | |
| Sub-Investigator: Robert L. Schelonka, MD | |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Krisa P. Van Meurs, MD 650-723-5711 vanmeurs@leland.stanford.edu | |
| Contact: M. Bethany Ball, BS CCRC (650) 725-8342 mbball@stanford.edu | |
| Principal Investigator: Krisa P. Van Meurs, MD | |
| Principal Investigator: David K. Stevenson, MD | |
| United States, Connecticut | |
| Yale University | Recruiting |
| New Haven, Connecticut, United States, 06504 | |
| Contact: Richard A. Ehrenkranz, MD 203-688-2895 richard.ehrenkranz@yale.edu | |
| Contact: Monica Konstantino, RN BSN (203) 688-7987 monica.konstantino@yale.edu | |
| Principal Investigator: Richard A. Ehrenkranz, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Barbara J. Stoll, MD 404-727-5740 barbara_stoll@oz.ped.emory.edu | |
| Contact: Ellen Hale, RN BS (404) 616-4218 ellen_hale@oz.ped.emory.edu | |
| Principal Investigator: Barbara J. Stoll, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Brenda B. Poindexter, MD MS 317-274-3592 bpoindex@iupui.edu | |
| Contact: Leslie D. Wilson, RN BSN (317) 274-8255 ldw@iupui.edu | |
| Principal Investigator: Brenda B. Poindexter, MD MS | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Edward F. Bell, MD 319-356-4006 edward-bell@uiowa.edu | |
| Contact: Karen J. Johnson, RN BSN (319) 356-2924 karen-johnson@uiowa.edu | |
| Principal Investigator: Edward F. Bell, MD | |
| United States, Massachusetts | |
| Tufts Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Ivan D. Frantz III, MD 617-636-5322 ifrantz@tufts-nemc.org | |
| Contact: Brenda L. MacKinnon, RNC (617) 636-1218 bmackinnon@tufts-nemc.org | |
| Principal Investigator: Ivan D. Frantz III, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Seetha Shankaran, MD 313-580-4452 sshankar@med.wayne.edu | |
| Contact: Rebecca Bara, RN BSN (313) 745-1436 rbara@med.wayne.edu | |
| Principal Investigator: Seetha Shankaran, MD | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Kristi L. Watterberg, MD 505-272-3967 kwatterberg@salud.unm.edu | |
| Contact: Conra Backstrom Lacy, RN (505) 272-0367 cbackstrom@salud.unm.edu | |
| Principal Investigator: Kristi L. Watterberg, MD | |
| United States, North Carolina | |
| RTI International | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Abhik Das, PhD 301-770-8214 adas@rti.org | |
| Contact: Kristin Zaterka-Baxter, RN (919) 485-7750 kzaterka@rti.org | |
| Principal Investigator: Abhik Das, PhD | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Ronald N. Goldberg, MD 919-681-6025 goldb008@mc.duke.edu | |
| Contact: Katherine A. Foy (919) 668-3360 foy00004@mc.duke.edu | |
| Principal Investigator: Ronald N. Goldberg, MD | |
| United States, Ohio | |
| Case Western Reserve University | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Michele C. Walsh, MD MS 216-844-3759 mcw3@cwru.edu | |
| Contact: Nancy S. Newman, BA RN (216) 368-3084 nxs5@cwru.edu | |
| Principal Investigator: Michele C. Walsh, MD MS | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Kurt Schibler, MD 513-636-3972 kurt.schibler@cchmc.org | |
| Contact: Cathy Grisby, BSN CCRC (513) 558-4953 grisbyca@email.uc.edu | |
| Principal Investigator: Kurt Schibler, MD | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Abbot R. Laptook, MD 401-274-1122 alaptook@WIHRI.org | |
| Contact: Angelita Hensman (401) 274-1122 ahensman@wihri.org | |
| Principal Investigator: Abbot R. Laptook, MD | |
| Sub-Investigator: William Oh, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Pablo J. Sanchez, MD 214-648-3753 Pablo.Sanchez@UTSouthwestern.edu | |
| Contact: Nancy A. Miller, RN (214) 648-3780 Nancy.Miller@UTSouthwestern.edu | |
| Principal Investigator: Pablo J. Sanchez, MD | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Kathleen A. Kennedy, MD MPH 713-500-6708 Kathleen.A.Kennedy@uth.tmc.edu | |
| Contact: Georgia E. McDavid, RN (713) 500-5734 Georgia.E.McDavid@uth.tmc.edu | |
| Principal Investigator: Kathleen A. Kennedy, MD MPH | |
| Principal Investigator: Jon E. Tyson, MD MPH | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Contact: Roger G. Faix, MD 801-581-7052 roger.faix@hsc.utah.edu | |
| Contact: Karen A. Osborne, RN BSN (801) 213-3298 karen.osborne@hsc.utah.edu | |
| Principal Investigator: Roger G. Faix, MD | |
| Principal Investigator: | Abbot R. Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island |
| Principal Investigator: | Michele C. Walsh, MD MS | Case Western Reserve University |
| Principal Investigator: | Ronald N. Goldberg, MD | Duke University |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University |
| Principal Investigator: | Brenda B. Poindexter, MD MS | Indiana University |
| Principal Investigator: | Abhik Das, PhD | RTI International |
| Principal Investigator: | Krisa P. Van Meurs, MD | Stanford University |
| Principal Investigator: | Ivan D. Frantz III, MD | Tufts Medical Center |
| Principal Investigator: | Kurt Schibler, MD | University of Cincinnati |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham |
| Principal Investigator: | Edward F. Bell, MD | University of Iowa |
| Principal Investigator: | Kristi L. Watterberg, MD | University of New Mexico |
| Principal Investigator: | Pablo J. Sanchez, MD | University of Texas Southwestern Medical Center at Dallas |
| Principal Investigator: | Kathleen A. Kennedy, MD MPH | The University of Texas Health Science Center, Houston |
| Principal Investigator: | Roger G. Faix, MD | University of Utah |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University |
More Information
| Responsible Party: | Brown University, Women & Infants Hospital of Rhode Island ( Abbot R. Laptook, MD ) |
| Study ID Numbers: | NICHD-NRN-0036, CCTS KL2 RR24149 (Houston), CCTS UL1 RR24128 (Duke), CCTS UL1 RR24139 (Yale), CCTS UL1 RR24148 (Houston), CCTS UL1 RR24979 (Iowa), CCTS UL1 RR24982 (Dallas), CCTS UL1 RR24989 (Case), CCTS UL1 RR25008 (Emory), CCTS UL1 RR25744 (Stanford), CCTS UL1 RR25752 (Tufts), CCTS UL1 RR25761 (Indiana), CCTS UL1 RR25764 (Utah), CCTS UL1 RR25777 (Alabama), GCRC M01 RR30 (Duke), GCRC M01 RR32 (Alabama), GCRC M01 RR54 (Tufts), GCRC M01 RR59 (Iowa), GCRC M01 RR633 (Dallas), GCRC M01 RR64 (Utah), GCRC M01 RR70 (Stanford), GCRC M01 RR750 (Indiana), GCRC M01 RR80 (Case), GCRC M01 RR8084 (Cinn), U01 HD36790 (RTI), U10 HD21364 (Case), U10 HD21373 (Houston), U10 HD21385 (Wayne), U10 HD27851 (Emory), U10 HD27853 (Cinn), U10 HD27856 (Indiana), U10 HD27871 (Yale), U10 HD27880 (Stanford), U10 HD27904 (Brown), U10 HD34216 (Alabama), U10 HD40492 (Duke), U10 HD40689 (Dallas), U10 HD53089 (New Mexico), U10 HD53109 (Iowa), U10 HD53119 (Tufts), U10 HD53124 (Utah) |
| Study First Received: | February 11, 2008 |
| Last Updated: | December 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00614744 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
NICHD Neonatal Research Network Hypoxic-ischemic encephalopathy (HIE) Hypothermia Neonatal depression Perinatal asphyxia |
|
Liver Diseases Neurotoxicity Syndromes Brain Damage, Chronic Hypoxia, Brain Disorders of Environmental Origin Brain Diseases Cerebrovascular Disorders Signs and Symptoms Hypoxia-Ischemia, Brain Mental Disorders Signs and Symptoms, Respiratory Brain Ischemia Brain Injuries Dementia Neurobehavioral Manifestations |
Hepatic Insufficiency Delirium Liver Failure Hypothermia Metabolic Diseases Depression Neurotoxicity syndromes Poisoning Vascular Diseases Central Nervous System Diseases Confusion Ischemia Depressive Disorder Encephalitis Cognition Disorders |
|
Pathologic Processes Nervous System Diseases Central Nervous System Viral Diseases Cardiovascular Diseases Body Temperature Changes |
